Fortress Biotech (FBIO) AI Stock Analysis

• Market Cap: $113.91M
• Dividend Yield: N/A
• Average Volume (3M): 1.34M
• Price to Earnings (P/E): ―
• Beta (1Y): 1.00
• Revenue Growth: -0.32%
• EPS Growth: 94.05%
• Country: US
• Employees: 101
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): 0.11
• Shares Outstanding: 31,037,937
• 10 Day Avg. Volume: 683,913
• 30 Day Avg. Volume: 1,343,678
• PEG Ratio: 0.01
• Price to Book (P/B): 1.86
• Price to Sales (P/S): 0.73
• P/FCF Ratio: -0.44
• Enterprise Value/Market Cap: 0.38
• Enterprise Value/Revenue: 0.70
• Enterprise Value/Gross Profit: 1.07
• Enterprise Value/Ebitda: -1.13
• 1Y Price Target: $10.75
• Price Target Upside: 192.92% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 2
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 54 Neutral
• Price Target: $3.50 ▼(-4.63% Downside)

The overall stock score is primarily impacted by the company's weak financial performance, characterized by declining revenues and high leverage. Positive technical indicators and strong earnings call results provide some optimism, but valuation concerns and regulatory challenges temper the outlook.

Positive Factors

Regulatory Advancement

The FDA's acceptance of CUTX-101's NDA resubmission marks a significant regulatory step, potentially leading to new revenue streams and enhancing the company's market position in treating Menkes disease.

Product Launch Success

The successful launch and growing adoption of EMROSI indicate strong market demand and potential for sustained revenue growth, improving the company's competitive position in the dermatology market.

Market Access Achievements

Achieving broad market access for EMROSI enhances its commercial potential, supporting long-term revenue growth and strengthening the company's market presence.

Negative Factors

Financial Instability

Persistent financial instability, characterized by declining revenues and high leverage, poses significant risks to the company's sustainability and ability to invest in future growth opportunities.

High Leverage

High leverage can limit financial flexibility and increase vulnerability to economic downturns, potentially impacting the company's ability to fund operations and strategic initiatives.

Negative Cash Flows

Negative cash flows highlight challenges in covering operational expenses, necessitating external financing and potentially hindering long-term financial health and growth prospects.

Fortress Biotech Business Overview & Revenue Model

Company Description

Fortress Biotech, Inc., a biopharmaceutical company, develops and commercializes pharmaceutical and biotechnology products. The company markets dermatology products, such as Ximino capsules to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris; Targadox for severe acne; Exelderm cream for ringworm and jock itch symptoms; Ceracade for dry skin conditions; Luxamend for dressing and managing wounds; and Accutane capsules for severe recalcitrant nodular acne. It also develops late stage product candidates, such as intravenous Tramadol for the treatment of post-operative acute pain; CUTX-101, an injection for the treatment of Menkes disease; MB-107 and MB-207 for the treatment of X-linked severe combined immunodeficiency; Cosibelimab for metastatic cancers; CK-101 for the treatment of patients with EGFR mutation-positive NSCLC; CAEL-101 for the treatment of amyloid light chain amyloidosis; Triplex vaccine for cytomegalovirus; and CEVA101 for the treatment of severe traumatic brain injury in adults and children. The company's early stage product candidates include MB-102 for blastic plasmacytoid dendritic cell neoplasm; MB-101 for glioblastoma; MB-104 for multiple myeloma and light chain amyloidosis; MB-106 for B-cell non-hodgkin lymphoma; MB-103 for GBM & metastatic breast cancer to brain; MB-108; MB-105 for prostate and pancreatic cancers; and BAER-101. Its preclinical product candidates comprise AAV-ATP7A gene therapy; AVTS-001 gene therapy; CK-103 BET inhibitor; CEVA-D and CEVA-102; CK-302, an anti-GITR; CK-303, an anti-CAIX; ConVax; and ONCOlogues, and oligonucleotide platform. It has collaboration arrangements with universities, research institutes, and pharmaceutical companies. The company was formerly known as Coronado Biosciences, Inc. and changed its name to Fortress Biotech, Inc. in April 2015. Fortress Biotech, Inc. was incorporated in 2006 and is based in Bay Harbor Island, New York.

How the Company Makes Money

Fortress Biotech generates revenue through multiple streams, primarily from the commercialization of its proprietary drug candidates and through collaborations with other pharmaceutical companies. The company earns revenue from licensing agreements, where they partner with larger pharmaceutical firms to develop and market their products, receiving milestone payments and royalties based on sales. Additionally, Fortress Biotech receives funding through equity investments and grants aimed at supporting research and development efforts. Significant partnerships with established pharmaceutical companies enhance their financial stability and broaden their market reach, contributing to their overall earnings.

Fortress Biotech Financial Statement Overview

Summary

Fortress Biotech is facing financial instability with declining revenues, persistent losses, and high leverage. The company shows negative profitability metrics and potential liquidity risks due to high debt levels. Cash flows are insufficient to cover operational needs, raising concerns about sustainability without external financing.

Income Statement

Fortress Biotech has experienced a challenging financial period with declining revenues from 2023 to 2024, and persistent net losses. The gross profit margin remains positive at approximately 100% due to negligible cost of goods sold, but the company faces a negative EBIT and EBITDA margin, indicating operational inefficiencies. The net profit margin is significantly negative, reflecting high net losses relative to total revenue. Revenue growth was negative in the latest year, indicating a contraction in sales.

Balance Sheet

The balance sheet shows high leverage with a debt-to-equity ratio indicating significant reliance on debt financing. Stockholders' equity has decreased over time, impacting the equity ratio negatively. The return on equity is negative due to continuous net losses, suggesting poor return on shareholders' investments. The current debt levels could pose a risk if profitability does not improve.

Cash Flow

The cash flow analysis reveals negative operating cash flows, indicating that the company is not generating sufficient cash from operations to cover its expenses. Free cash flow is also negative, pointing to challenges in creating value for shareholders. The operating cash flow to net income ratio is unfavorable due to significant cash outflows and net losses.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	62.30M	57.67M	84.51M	75.74M	68.79M	45.60M
Gross Profit	41.01M	36.80M	61.62M	44.97M	36.71M	31.00M
EBITDA	-38.77M	-104.49M	-135.72M	-193.69M	-146.17M	-87.82M
Net Income	3.99M	-46.00M	-60.64M	-86.58M	-64.70M	-46.53M
Balance Sheet
Total Assets	181.41M	144.22M	167.53M	294.30M	396.50M	333.41M
Cash, Cash Equivalents and Short-Term Investments	86.22M	57.26M	80.93M	178.27M	305.74M	233.35M
Total Debt	68.29M	75.96M	88.59M	127.34M	74.98M	89.08M
Total Liabilities	116.22M	145.87M	165.94M	244.28M	170.63M	136.41M
Stockholders Equity	55.86M	22.74M	22.54M	41.72M	108.67M	100.34M
Cash Flow
Free Cash Flow	-66.14M	-95.19M	-136.32M	-182.46M	-132.89M	-90.85M
Operating Cash Flow	-66.14M	-80.19M	-128.22M	-179.40M	-116.54M	-83.68M
Investing Cash Flow	-4.88M	-15.00M	-2.10M	-22.93M	40.51M	-7.16M
Financing Cash Flow	97.54M	70.64M	32.74M	75.32M	148.99M	172.41M

Fortress Biotech Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 3.67
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• RSI: Negative
• STOCH: Negative

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For FBIO, the sentiment is Positive. The current price of 3.67 is above the 20-day moving average (MA) of 3.08, above the 50-day MA of 2.79, and above the 200-day MA of 2.30, indicating a bullish trend. The MACD of 0.25 indicates Negative momentum. The RSI at 72.58 is Negative, neither overbought nor oversold. The STOCH value of 86.27 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for FBIO.

Fortress Biotech Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
RPTX	60 Neutral	$109.93M	-1.51	-49.78%	―	-82.16%	14.58%
FBIO	54 Neutral	$113.91M	-13.71	10.35%	―	-0.32%	94.05%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
EQ	44 Neutral	$98.04M	-2.55	-90.24%	―	-90.43%	-382.07%
UNCY	28 Underperform	$125.94M	-1.80	-102.47%	―	―	66.05%
CVM	27 Underperform	$37.52M	-0.48	-328.04%	―	―	42.29%

Fortress Biotech Corporate Events

Fortress Biotech Amends Credit Agreement with Oaktree

On December 12, 2025, Fortress Biotech, Inc. amended its Credit Agreement with Oaktree Fund Administration, extending the loan maturity date to June 30, 2028, and adjusting the principal repayment schedule. The amendment also revised the financial covenant for Journey Medical Corporation’s net sales requirements, with specific targets set for each fiscal quarter through 2026. Additionally, Fortress Biotech granted warrants to lenders for purchasing shares of its common stock, with provisions for anti-dilution adjustments.

Fortress Biotech’s CUTX-101 NDA Resubmission Accepted by FDA

On December 15, 2025, Fortress Biotech announced that the U.S. FDA accepted the resubmission of the New Drug Application for CUTX-101 as a Class 1 resubmission. The FDA provided a target action date of January 14, 2026, indicating a significant step forward in the company’s efforts to bring this drug to market.

Fortress Biotech’s Subsidiary Resubmits NDA for CUTX-101

On November 14, 2025, Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, resubmitted the NDA for CUTX-101 to the FDA, a treatment for Menkes disease in pediatric patients. Cyprium retains ownership of any Priority Review Voucher from the NDA approval and stands to gain royalties and up to $129 million in development and sales milestones.

Fortress Biotech Receives FDA Response on CUTX-101

On October 1, 2025, Fortress Biotech, Inc. announced that the U.S. Food and Drug Administration issued a complete response letter for their product CUTX-101 (copper histidinate). This development may impact the company’s operations and its positioning within the pharmaceutical industry, as regulatory feedback can influence product timelines and stakeholder expectations.